Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
210
Countries
1
Sites
3
Respiratory Syncytial Virus Infections
Key facts
- Sponsor
- GlaxoSmithKline Biologicals
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Virus Diseases [C02]
- Trial duration
- 12 Nov 2024 → 14 Apr 2026
- Decision date (initial)
- 2024-10-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Respiratory Syncytial Virus Infections
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061603 | Respiratory syncytial virus infection | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
GlaxoSmithKline Biologicals
- Sponsor organisation
- GlaxoSmithKline Biologicals
- Address
- Rue De L'Institut 89
- City
- Rixensart
- Postcode
- 1330
- Country
- Belgium
Scientific contact point
- Organisation
- GlaxoSmithKline Biologicals
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- GlaxoSmithKline Biologicals
- Contact name
- EU GSK Clinical Trials Call Center
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 63 | 3 |
| Rest of world
United States, Australia
|
— | 147 | — |
Investigational sites
Hospital Universitario De La Princesa
Unidad de Ensayos Clínicos Fase 1, Calle De Diego De Leon 62, 28006, Madrid
Hospital Universitario La Paz
Servicio UCICEC, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Puerta De Hierro De Majadahonda
Servicio de Farmacología Clínica, Calle De Manuel De Falla 1, 28222, Majadahonda
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2024-11-12 | 2026-02-17 | 2024-11-12 | 2025-02-12 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-26 | Spain | Acceptable with conditions 2024-10-31
|
2024-10-31 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-27 | Spain | Acceptable with conditions 2024-10-31
|
2025-02-27 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-04 | Spain | Acceptable with conditions 2024-10-31
|
2025-04-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-14 | Spain | Acceptable 2025-06-30
|
2025-07-07 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-10-31 | Spain | Acceptable 2025-06-30
|
2025-10-31 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-02-05 | Spain | Acceptable 2025-06-30
|
2026-02-05 |